University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
NCT Number: NCT03472937
The investigators are performing a randomized controlled trial investigating starting cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley catheter. The objective of the study is to determine if outpatient compared to inpatient cervical ripening with a transcervical Foley catheter in nulliparous women undergoing induction shortens the time spent in labor and delivery (from the time of admission to the time of delivery).
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Notify Me18 year and older
Female
Interventional
Not applicable
Birmingham, Alabama, 35233, United States
Approximately 20-25% of pregnant women undergo an induction of labor, and a large percentage of these women require cervical ripening in order to "ready" the cervix for induction. In the setting of an unfavorable cervix, induction of labor with oxytocin alone can be associated with longer times to delivery, uterine tachysystole (uterine contractions that are too frequent), and increased rates of cesarean delivery.
Outpatient cervical ripening is an attractive option for both women and their physicians, as this allows for the potential to spend less time in the hospital and more time in the comforts of the patient's own home.
The investigators will conduct a randomized controlled trial comparing outpatient to inpatient cervical ripening using a transcervical Foley catheter. Women will be randomized to undergo inpatient or outpatient transcervical Foley catheter cervical ripening beyond their 39th week of gestation. Women and their infants will be followed until the time of their discharge from the hospital.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will be randomized have cervical ripening with a transcervical Foley catheter in either the inpatient or outpatient setting.
Time frame: From baseline to the time of delivery (baseline is from admission)
Time frame: At baseline
Time frame: Within 2-4 days after delivery
Assessed through survey adapted from "Six Simple Questions Survey," which has been published by Harvey et al (Harvey et al. Evaluation of satisfaction with midwifery care. Midwifery. 2002 Dec; 18(4):260-7.) This survey has 6 questions to assess perceptions of satisfaction with care. The questions include questions such as, "I had appropriate and adequate control over my care," "The person(s) responsible for my care are/were caring and compassionate," and "Problems that have arisen up to now have not been dealt with effectively." The scare ranges from 1-7, with 1 representing Strongly Disagree and 7 representing Strongly Agree.
Time frame: Within 2-4 days after delivery
Assessed through survey adapted from "Labor and Delivery Index (LADY-X" Survey, which has been published by Gartner et al (Gartner et al. Calculating Preference Weights for the Labor and Delivery Index: A Discrete Choice Experiment on Women's Birth Experiences. Value Health. 2015 Sep; 18(6):856-864.) This survey has 7 questions to assess experiences during labor and birth. Each question then has 3 answer choices that describe how good/poor the experience was. An example of a question is, "Taking your wishes seriously during childbirth." The answers then include "very seriously, sufficiently seriously, or insufficiently seriously."
Time frame: From placement of Foley bulb to delivery
Assessed through survey that contains 4 questions. The first 3 questions assess pain (worst pain during labor, overall pain during labor, and worse pain during placement of the Foley balloon). The 4th question asks how likely a patient is to recommend her method of induction to a friend/family member. The scale ranges from 0-100, with 0 representing no pain or very unlikely and 100 representing pain as bad as it could possibly be or very likely. The patient is instructed to place a hash mark over the line.
Time frame: From placement of Foley bulb to delivery
Vaginal bleeding that is like a period or more
Time frame: From hospital admission to hospital discharge (generally less than one week)
Time frame: From placement of Foley bulb to 24 hours
Time frame: From placement of Foley bulb to 24 hours
Time frame: From placement of Foley bulb to 24 hours
Time frame: From placement of Foley bulb to 24 hours
Time frame: From placement of Foley bulb to 30 minutes
Time frame: From baseline to delivery
Time frame: From baseline to delivery
Time frame: From baseline to delivery
Time frame: From baseline to delivery
Time frame: From baseline to delivery
Time frame: From delivery until 30 days post-discharge
Time frame: From baseline to delivery
Rates of vaginal delivery, cesarean delivery, and operative vaginal delivery (vacuum or forceps)
Time frame: At delivery
Time frame: From hospital discharge until 30 days post-discharge
Time frame: From time of delivery up to 5 minutes post-delivery
Time frame: From time of delivery up to 5 minutes post-delivery
Time frame: From time of delivery up to 5 minutes post-delivery
Time frame: After delivery and before neonatal discharge (generally less than one week)
University of Alabama at Birmingham
Other
Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women: A Randomized-Controlled Study
Acronym: OFFSITE II
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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